Laryngeal Mask Supreme™ Versus the I-gel™
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Purpose
We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.
| Condition | Intervention |
|---|---|
|
Patients Undergoing Elective General Anesthesia |
Device: I-gel and LMA Supreme: supraglottic airway devices |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients |
- first attempt success rate and time to success [ Time Frame: during intervention ] [ Designated as safety issue: Yes ]
- leak pressure [ Time Frame: during intervention ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | March 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
crossover trial. insertion of both devices consecutively, computer randomized order
|
Device: I-gel and LMA Supreme: supraglottic airway devices
Insertion of a supraglottic airway device
Other Name: Laryngeal Mask Supreme, supraglottic airway device
|
Detailed Description:
The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ASA 1-3 patients undergoing elective operation
Exclusion Criteria:
- Not speaking german or refusing to participate
- BMI >35, <50kg
- Planned operation time >4h
- High risk of aspiration
- Cervical spine disease, known difficult airway, mouth opening <20mm
- Upper respiratory tract symptoms in the previous 10 days
- Preoperative sore throat
- Poor dentition with high risk of damage
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00653237
| Switzerland | |
| University Hospital | |
| Berne, Switzerland, CH-3010 | |
| Study Director: | Robert Greif, M.D. | Department of Anesthesia, University Hospital Berne, Switzerland |
More Information
No publications provided
| Responsible Party: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT00653237 History of Changes |
| Other Study ID Numbers: | igellma-1 |
| Study First Received: | April 1, 2008 |
| Last Updated: | March 11, 2014 |
| Health Authority: | Switzerland: Federal Office of Public Health |
ClinicalTrials.gov processed this record on March 03, 2015